AU2018290995B2

AU2018290995B2 - System and method for identifying, marking and navigating to a target using real-time two-dimensional fluoroscopic data

Info

Publication number: AU2018290995B2
Application number: AU2018290995A
Authority: AU
Inventors: Guy Alexandroni; Ron Barak; Ariel Birenbaum; Benjamin GREENBURG; Efrat KEDMI-SHAHAR; Eyal KLEIN; Evgeni KOPEL; Dafna MARDIX; Oren P. Weingarten
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2017-06-29
Filing date: 2018-06-29
Publication date: 2022-07-07
Anticipated expiration: 2038-06-29
Also published as: US20210049796A1; EP3646289A1; JP7277386B2; JP2020526241A; US20220189082A1; AU2018290995A1; US20200286267A1; US10846893B2; US20190005687A1; US11341692B2; US10699448B2; CN110741414B; CN110741414A; EP3646289A4; CN117252948A; WO2019006258A1

Abstract

A system for facilitating identification and marking of a target in a fluoroscopic image of a body region of a patient, the system comprising one or more storage devices having stored thereon instructions for: receiving a CT scan and a fluoroscopic 3D reconstruction of the body region of the patient, wherein the CT scan includes a marking of the target; and generating at least one virtual fluoroscopy image based on the CT scan of the patient, wherein the virtual fluoroscopy image includes the target and the marking of the target, at least one hardware processor configured to execute these instructions, and a display configured to display to a user the virtual fluoroscopy image and the fluoroscopic 3D reconstruction.

Description

SYSTEM AND METHOD FOR IDENTIFYING, MARKING AND NAVIGATING TO A TARGET USING REAL-TIME TWO-DIMENSIONAL FLUOROSCOPIC DATA BACKGROUND

Technical Field

[0001] The present disclosure relates to the field of identifying and marking a

target in fluoroscopic images, in general, and to such target identification and marking in

medical procedures involving intra-body navigation, in particular. Furthermore, the

present disclosure relates to a system, apparatus, and method of navigation in medical

procedures.

Description of Related Art

[0002] There are several commonly applied medical methods, such as endoscopic

procedures or minimally invasive procedures, for treating various maladies affecting

organs including the liver, brain, heart, lung, gall bladder, kidney and bones. Often, one

or more imaging modalities, such as magnetic resonance imaging (MRI), ultrasound

imaging, computed tomography (CT), fluoroscopy as well as others are employed by

clinicians to identify and navigate to areas of interest within a patient and ultimately a

target for treatment. In some procedures, pre-operative scans may be utilized for target

identification and intraoperative guidance. However, real-time imaging may be often

required to obtain a more accurate and current image of the target area. Furthermore,

real-time image data displaying the current location of a medical device with respect to the

target and its surrounding may be required to navigate the medical device to the target in

a more safe and accurate manner (e.g., with unnecessary or no damage caused to other

organs or tissue).

[0003] For example, an endoscopic approach has proven useful in navigating to

areas of interest within a patient, and particularly so for areas within luminal networks of the body such as the lungs. To enable the endoscopic, and more particularly the bronchoscopic approach in the lungs, endobronchial navigation systems have been developed that use previously acquired MRI data or CT image data to generate a three-dimensional (3D) rendering, model or volume of the particular body part such as the lungs.

[0004] The resulting volume generated from the MRI scan or CT scan is then

utilized to create a navigation plan to facilitate the advancement of a navigation catheter

(or other suitable medical device) through a bronchoscope and a branch of the bronchus

of a patient to an area of interest. A locating or tracking system, such as an electromagnetic

(EM) tracking system, may be utilized in conjunction with, for example, CT data, to

facilitate guidance of the navigation catheter through the branch of the bronchus to the

area of interest. In certain instances, the navigation catheter may be positioned within one

of the airways of the branched luminal networks adjacent to, or within, the area of interest

to provide access for one or more medical instruments.

[0005] However, a three-dimensional volume of a patient's lungs, generated from

previously acquired scans, such as CT scans, may not provide a basis sufficient for

accurate guiding of medical instruments to a target during a navigation procedure. In

certain instances, the inaccuracy is caused by deformation of the patient's lungs during the

procedure relative to the lungs at the time of the acquisition of the previously acquired CT

data. This deformation (CT-to-Body divergence) may be caused by many different factors,

for example: sedation vs. no sedation, bronchoscope changing patient pose and also

pushing the tissue, different lung volume because CT was in inhale while navigation is

during breathing, different bed, day, etc.

[0006] Thus, another imaging modality is necessary to visualize such targets in

real-time and enhance the in-vivo navigation procedure by correcting navigation during the procedure. Furthermore, in order to accurately and safely navigate medical devices to a remote target, for example, for biopsy or treatment, both the medical device and the target should be visible in some sort of a three-dimensional guidance system.

[0007] A fluoroscopic imaging device is commonly located in the operating room

during navigation procedures. The standard fluoroscopic imaging device may be used by

a clinician, for example, to visualize and confirm the placement of a medical device after

it has been navigated to a desired location. However, although standard fluoroscopic

images display highly dense objects such as metal tools and bones as well as large soft

tissue objects such as the heart, the fluoroscopic images may have difficulty resolving

small soft-tissue objects of interest such as lesions. Furthermore, the fluoroscope image

is only a two-dimensional projection. Therefore, an X-ray volumetric reconstruction may

enable identification of such soft tissue objects and navigation to the target.

[0008] Several solutions exist that provide three-dimensional volume

reconstruction such as CT and Cone-beam CT which are extensively used in the medical

world. These machines algorithmically combine multiple X-ray projections from known,

calibrated X-ray source positions into three-dimensional volume in which, inter alia, soft

tissues are more visible. For example, a CT machine can be used with iterative scans during

procedure to provide guidance through the body until the tools reach the target. This is a

tedious procedure as it requires several full CT scans, a dedicated CT room and blind

navigation between scans. In addition, each scan requires the staff to leave the room due

to high-levels of ionizing radiation and exposes the patient to such radiation. Another

option is a Cone-beam CT machine, which is available in some operation rooms and is

somewhat easier to operate but is expensive and like the CT only provides blind navigation

between scans, requires multiple iterations for navigation and requires the staff to leave the room. In addition, a CT-based imaging system is extremely costly, and in many cases not available in the same location as the location where a procedure is carried out.

[0009] Hence, an imaging technology, which uses standard fluoroscope devices,

to reconstruct local three-dimensional volume in order to visualize and facilitate

navigation to in-vivo targets, and to small soft-tissue objects in particular, has been

introduced: US Patent Application No. 2017/035379 to Weingarten et al. entitled

SYSTEMS AND METHODS FOR LOCAL THREE DIMENSIONAL VOLUME

RECONSTRUCTION USING A STANDARD FLUOROSCOPE, the contents of which

are incorporated herein by reference, US Patent Application No. 2017/035380 to Barak et

al. entitled SYSTEM AND METHOD FOR NAVIGATING TO TARGET AND

PERFORMING PROCEDURE ON TARGET UTILIZING FLUOROSCOPIC-BASED

LOCAL THEREE DIMENSIONAL VOLUME RECONSTRUCTION, the contents of

which are incorporated herein by reference and US Patent Application No. 15/892,053 to

Weingarten et al. entitled SYSTEMS AND METHODS FOR LOCAL THREE

DIMENSIONAL VOLUME RECONSTRUCTION USING A STANDARD

FLUOROSCOPE, the contents of which are incorporated herein by reference.

[0010] In general, according to the systems and methods disclosed in the above

mentioned patent applications, a standard fluoroscope c-arm can be rotated, e.g., about 30

degrees, around a patient during a medical procedure, and a fluoroscopic 3D reconstruction

of the region of interest is generated by a specialized software algorithm. The user can then

scroll through the image slices of the fluoroscopic 3D reconstruction using the software

interface to identify the target (e.g., a lesion) and mark it.

[0011] Such quick generation of a 3D reconstruction of a region of interest can

provide real-time three-dimensional imaging of the target area. Real-time imaging of the

target and medical devices positioned in its area may benefit numerous interventional procedures, such as biopsy and ablation procedures in various organs, vascular interventions and orthopedic surgeries. For example, when navigational bronchoscopy is concerned, the aim may be to receive accurate information about the position of a biopsy catheter relative to a target lesion.

[0012] As another example, minimally invasive procedures, such as laparoscopy

procedures, including robotic-assisted surgery, may employ intraoperative fluoroscopy to

increase visualization, e.g., for guidance and lesion locating, and to prevent unnecessary injury

and complications. Employing the above-mentioned systems and methods for real-time

reconstruction of fluoroscopic three-dimensional imaging of a target area and for navigation based

on the reconstruction may benefit such procedures as well.

[0013] Still, it may not be an easy task to accurately identify and mark a target in the

fluoroscopic 3D reconstruction, in particular when the target is a small soft-tissue. Thus, there is

a need for systems and methods for facilitating the identification and marking of a target in

fluoroscopic image data, and in a fluoroscopic 3D reconstruction in particular, to consequently

facilitate the navigation to the target and the yield of pertinent medical procedures.

SUMMARY

[0013a] According to an aspect of the present invention, there is provided a system

for facilitating identification and marking of a target in a target area in a fluoroscopic image

of a body region of a patient, the system comprising: (i) one or more storage devices

having stored thereon instructions for: receiving a CT scan of the body region of the

patient, wherein the CT scan includes a marking of the target; receiving a sequence of

fluoroscopic images including the target area acquired in real-time about a plurality of

angles relative to the target, while a medical device is positioned in proximity to the target;

and generating a fluoroscopic 3D reconstruction based on at least a portion of the sequence

of fluoroscopic images; generating at least one virtual fluoroscopic image based on the CT

scan of the patient, wherein the virtual fluoroscopic image includes the target and the marking of the target, receiving a selection of the target in the fluoroscopic 3D reconstruction via a user input; receiving a selection of the medical device in the 3D reconstruction or the sequence of fluoroscopic images; determining an offset of the medical device with respect to the target based on the selections of the target and the medical device; determining a location of the medical device within the patient based on data provided by a tracking system; displaying the target area and the location of the medical device with respect to the target on a display; and correcting the display of the location of the medical device with respect to the target based on the offset between the medical device and the target; and (ii) at least one hardware processor configured to execute said instructions.

[00141 There is provided in accordance with the present disclosure, a system for

facilitating identification and marking of a target in a fluoroscopic image of a body region of a

patient, the system comprising: (i) one or more storage devices having stored thereon instructions

for: receiving a CT scan and a fluoroscopic 3D reconstruction of the body region of the patient,

wherein the CT scan includes a marking of the target; generating at least one virtual fluoroscopy

image based on the CT scan of the patient, wherein the virtual fluoroscopy image includes the

target and the marking of the target, (ii) at least one hardware processor configured to

execute said instructions, and (iii) a display configured to display to a user the virtual fluoroscopy image simultaneously with the fluoroscopic 3D reconstruction.

[0015] There is further provided in accordance with the present disclosure, a

system for facilitating identification and marking of a target in a fluoroscopic image of a

body region of a patient, the system comprising: (i) one or more storage devices having

stored thereon instructions for: receiving a CT scan and a fluoroscopic 3D reconstruction

of the body region of the patient, wherein the CT scan includes a marking of the target;

generating at least one virtual fluoroscopy image based on the CT scan of the patient,

wherein the virtual fluoroscopy image includes the target and the marking of the target,

(ii) at least one hardware processor configured to execute said instructions, and (iii) a

display configured to display to a user the virtual fluoroscopy image and the fluoroscopic

3D reconstruction.

[0016] There is further provided in accordance with the present disclosure, a

method for identifying and marking a target in an image of a body region of a patient, the

method comprising using at least one hardware processor for: receiving a CT scan and a

fluoroscopic 3D reconstruction of the body region of the patient, wherein the CT scan

includes a marking of the target; generating at least one virtual fluoroscopy image based

on the CT scan of the patient, wherein the at least one virtual fluoroscopy image includes

the target and the marking of the target; and displaying to a user the at least one virtual

fluoroscopy image simultaneously with the fluoroscopic 3D reconstruction on a display,

thereby facilitating the identification of the target in the fluoroscopic 3D reconstruction by

the user.

[0017] There is further provided in accordance with the present disclosure, a

method comprising using at least one hardware processor for: receiving a CT scan and a fluoroscopic 3D reconstruction of the body region of the patient, wherein the CT scan includes a marking of the target; generating at least one virtual fluoroscopy image based on the CT scan of the patient, wherein the at least one virtual fluoroscopy image includes the target and the marking of the target; and displaying to a user the at least one virtual fluoroscopy image and the fluoroscopic 3D reconstruction on a display, thereby facilitating the identification of the target in the fluoroscopic 3D reconstruction by the user.

[0018] There is further provided in accordance with the present disclosure, a

system for navigating to a target area within a patient's body during a medical procedure

using real-time two-dimensional fluoroscopic images, the system comprising: a medical

device configured to be navigated to the target area; a fluoroscopic imaging device

configured to acquire a sequence of 2D fluoroscopic images of the target area about a

plurality of angles relative to the target area, while the medical device is positioned in the

target area; and a computing device configured to: receive a pre-operative CT scan of the

target area, wherein the pre-operative CT scan includes a marking of the target; generate

at least one virtual fluoroscopy image based on the pre-operative CT scan, wherein the at

least one virtual fluoroscopy image includes the target and the marking of the target;

generate a three-dimensional reconstruction of the target area based on the acquired

sequence of 2D fluoroscopic images; display to a user the at least one virtual fluoroscopy

image and the fluoroscopic 3D reconstruction simultaneously, receive a selection of the

target from the fluoroscopic 3D reconstruction via the user; receive a selection of the

medical device from the three-dimensional reconstruction or the sequence of 2D

fluoroscopic images; and determine an offset of the medical device with respect to the

target based on the selections of the target and the medical device.

[0019] There is further provided in accordance with the present disclosure, a

system for navigating to a target area within a patient's body during a medical procedure using real-time two-dimensional fluoroscopic images, the system comprising: a medical device configured to be navigated to the target area; a fluoroscopic imaging device configured to acquire a sequence of 2D fluoroscopic images of the target area about a plurality of angles relative to the target area, while the medical device is positioned in the target area; and a computing device configured to: receive a pre-operative CT scan of the target area, wherein the pre-operative CT scan includes a marking of the target; generate at least one virtual fluoroscopy image based on the pre-operative CT scan, wherein the at least one virtual fluoroscopy image includes the target and the marking of the target; generate a three-dimensional reconstruction of the target area based on the acquired sequence of 2D fluoroscopic images; display to a user the at least one virtual fluoroscopy image and the fluoroscopic 3D reconstruction, receive a selection of the target from the fluoroscopic 3D reconstruction via the user; receive a selection of the medical device from the three-dimensional reconstruction or the sequence of 2D fluoroscopic images; and determine an offset of the medical device with respect to the target based on the selections of the target and the medical device.

[0020] There is further provided in accordance with the present disclosure, a

method for navigating to a target area within a patient's body during a medical procedure

using real-time two-dimensional fluoroscopic images, the method comprising using at

least one hardware processor for: receiving a pre-operative CT scan of the target area,

wherein the pre-operative CT scan includes a marking of the target; generating at least one

virtual fluoroscopy image based on the pre-operative CT scan, wherein the at least one

virtual fluoroscopy image includes the target and the marking of the target; receiving a

sequence of 2D fluoroscopic images of the target area acquired in real-time about a

plurality of angles relative to the target area, while a medical device is positioned in the

target area; generating a three-dimensional reconstruction of the target area based on the sequence of 2D fluoroscopic images; displaying to a user the at least one virtual fluoroscopy image and the fluoroscopic 3D reconstruction simultaneously, receiving a selection of the target from the fluoroscopic 3D reconstruction via the user; receiving a selection of the medical device from the three-dimensional reconstruction or the sequence of 2D fluoroscopic images; and determining an offset of the medical device with respect to the target based on the selections of the target and the medical device.

[0021] There is further provided in accordance with the present disclosure, a

target area; generating a three-dimensional reconstruction of the target area based on the

sequence of 2D fluoroscopic images; displaying to a user the at least one virtual

fluoroscopy image and the fluoroscopic 3D reconstruction, receiving a selection of the

target from the fluoroscopic 3D reconstruction via the user; receiving a selection of the

medical device from the three-dimensional reconstruction or the sequence of 2D

fluoroscopic images; and determining an offset of the medical device with respect to the

target based on the selections of the target and the medical device.

[0022] There is further provided in accordance with the present disclosure, a

computer program product comprising a non-transitory computer-readable storage

medium having program code embodied therewith, the program code executable by at least one hardware processor to: receive a pre-operative CT scan of the target area, wherein the pre-operative CT scan includes a marking of the target; generate at least one virtual fluoroscopy image based on the pre-operative CT scan, wherein the at least one virtual fluoroscopy image includes the target and the marking of the target; receive a sequence of

2D fluoroscopic images of the target area acquired in real-time about a plurality of angles

relative to the target area, while a medical device is positioned in the target area; generate

a fluoroscopic three-dimensional reconstruction of the target area based on the sequence

of 2D fluoroscopic images; display to a user the at least one virtual fluoroscopy image and

the fluoroscopic three-dimensional reconstruction simultaneously, receive a selection of

the target from the fluoroscopic three-dimensional reconstruction via the user; receive a

selection of the medical device from the fluoroscopic three-dimensional reconstruction or

the sequence of 2D fluoroscopic images; and determine an offset of the medical device

with respect to the target based on the selections of the target and the medical device.

[0023] There is further provided in accordance with the present disclosure, a

computer program product comprising a non-transitory computer-readable storage

medium having program code embodied therewith, the program code executable by at

least one hardware processor to: receive a pre-operative CT scan of the target area, wherein

the pre-operative CT scan includes a marking of the target; generate at least one virtual

fluoroscopy image based on the pre-operative CT scan, wherein the at least one virtual

fluoroscopy image includes the target and the marking of the target; receive a sequence of

the fluoroscopic three-dimensional reconstruction, receive a selection of the target from the fluoroscopic three-dimensional reconstruction via the user; receive a selection of the medical device from the fluoroscopic three-dimensional reconstruction or the sequence of

2D fluoroscopic images; and determine an offset of the medical device with respect to the

target based on the selections of the target and the medical device.

[0024] In another aspect of the present disclosure, the one or more storage devices

have stored thereon further instructions for directing the user to identify and mark the

target in the fluoroscopic 3D reconstruction.

[0025] In another aspect of the present disclosure, the one or more storage devices

target in the fluoroscopic 3D reconstruction while using the virtual fluoroscopy image as

a reference.

[0026] In another aspect of the present disclosure, the one or more storage devices

target in two fluoroscopic slice images of the fluoroscopic 3D reconstruction captured at

two different angles.

[0027] In another aspect of the present disclosure, the generating of the at least one

virtual fluoroscopy image is based on Digitally Reconstructed Radiograph techniques.

[0028] In another aspect of the present disclosure, the generating of the at least one

virtual fluoroscopy image comprises: generating virtual fluoroscope poses around the

target by simulating a fluoroscope trajectory while scanning the target; generating virtual

2D fluoroscopic images by projecting the CT scan volume according to the virtual

fluoroscope poses; generating virtual fluoroscopic 3D reconstruction based on the virtual

2D fluoroscopic images; and selecting a slice image from the virtual fluoroscopic 3D

reconstruction which comprises the marking of the target.

[0029] In another aspect of the present disclosure, the target is a soft-tissue target.

[0030] In another aspect of the present disclosure, the receiving of the fluoroscopic

3D reconstruction of the body region comprises: receiving a sequence of 2D fluoroscopic

images of the body region acquired about a plurality of angles relative to the body region

and generating the fluoroscopic 3D reconstruction of the body region based on the

sequence of 2D fluoroscopic images.

[0031] In another aspect of the present disclosure, the method further comprises

using said at least one hardware processor for directing the user to identify and mark the

target in the fluoroscopic 3D reconstruction.

[0032] In another aspect of the present disclosure, the method further comprises

target in the fluoroscopic 3D reconstruction while using the at least one virtual fluoroscopy

image as a reference.

[0033] In another aspect of the present disclosure, the method further comprises

using said at least one hardware processor for instructing the user to identify and mark the

two different angles.

[0034] In another aspect of the present disclosure, the system further comprises: a

tracking system configured to provide data indicating the location of the medical device

within the patient's body; and a display, wherein the computing device is further

configured to: determine the location of the medical device based on the data provided by

the tracking system; display the target area and the location of the medical device with

respect to the target on the display; and correct the display of the location of the medical

device with respect to the target based on the determined offset between the medical device

and the target.

[0035] In another aspect of the present disclosure, the computing device is further

configured to: generate a 3D rendering of the target area based on the pre-operative CT

scan, wherein the display of the target area comprises displaying the 3D rendering; and

register the tracking system to the 3D rendering, wherein the correction of the location of

the medical device with respect to the target comprises updating the registration between

the tracking system and the 3D rendering.

[0036] In another aspect of the present disclosure, the tracking system comprises:

a sensor; and an electromagnetic field generator configured to generate an electromagnetic

field for determining a location of the sensor, wherein the medical device comprises a

catheter guide assembly having the sensor disposed thereon, and the determining of the

location of the medical device comprises determining the location of the sensor based on

the generated electromagnetic field.

[0037] In another aspect of the present disclosure, the target area comprises at least

a portion of the lungs and the medical device is configured to be navigated to the target

area through the airways luminal network.

[0038] In another aspect of the present disclosure, the computing device is

configured to receive the selection of the medical device by automatically detecting a

portion of the medical device in the acquired sequence of 2D fluoroscopic images or three

dimensional reconstruction and receiving the user command either accepting or rejecting

the detection.

[0039] In another aspect of the present disclosure, the computing device is further

configured to estimate the pose of the fluoroscopic imaging device, while the fluoroscopic

imaging device acquires each of at least a plurality of images of the sequence of 2D

fluoroscopic images, and wherein the generating of the three-dimensional reconstruction

of the target area is based on the pose estimation of the fluoroscopic imaging device.

[0040] In another aspect of the present disclosure, the system further comprises a

structure of markers, wherein the fluoroscopic imaging device is configured to acquire a

sequence of 2D fluoroscopic images of the target area and of the structure of markers, and

wherein the estimation of the pose of the fluoroscopic imaging device while acquiring each

image of the at least plurality of images is based on detection of a possible and most

probable projection of the structure of markers, as a whole, on each image.

[0041] In another aspect of the present disclosure, the computing device is further

configured to direct the user to identify and mark the target in the fluoroscopic 3D

reconstruction while using the at least one virtual fluoroscopy image as a reference.

[0042] In another aspect of the present disclosure, the method further comprises

using said at least one hardware processor for: determining the location of the medical

device within the patient's body based on data provided by a tracking system; displaying

the target area and the location of the medical device with respect to the target on a display;

and correcting the display of the location of the medical device with respect to the target

based on the determined offset between the medical device and the target.

[0043] In another aspect of the present disclosure, the method further comprises

using said at least one hardware processor for: generating a 3D rendering of the target area

based on the pre-operative CT scan, wherein the displaying of the target area comprises

displaying the 3D rendering; and registering the tracking system to the 3D rendering,

wherein the correcting of the location of the medical device with respect to the target

comprises updating the registration between the tracking system and the 3D rendering.

[0044] In another aspect of the present disclosure, the receiving of the selection of

the medical device comprises automatically detecting a portion of the medical device in

the sequence of 2D fluoroscopic images or three-dimensional reconstruction and receiving

the user command either accepting or rejecting the detection.

[0045] In another aspect of the present disclosure, the method further comprises

using said at least one hardware processor for estimating the pose of the fluoroscopic

imaging device while acquiring each of at least a plurality of images of the sequence of

2D fluoroscopic images, wherein the generating of the three-dimensional reconstruction

[0046] In another aspect of the present disclosure, a structure of markers is placed

with respect to the patient and the fluoroscopic imaging device such that each image of the

at least plurality of images comprises a projection of at least a portion of the structure of

markers, and wherein the estimating of the pose of the fluoroscopic imaging device while

acquiring each image of the at least plurality of images is based on detection of a possible

and most probable projection of the structure of markers as a whole on each image.

[0047] In another aspect of the present disclosure, the non-transitory computer

readable storage medium has further program code executable by the at least one hardware

processor to: determine the location of the medical device within the patient's body based

on data provided by a tracking system; display the target area and the location of the

medical device with respect to the target on a display; and correct the display of the

location of the medical device with respect to the target based on the determined offset

between the medical device and the target.

[0048] Any of the above aspects and embodiments of the present disclosure may

be combined without departing from the scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Various aspects and embodiments of the present disclosure are described

hereinbelow with references to the drawings, wherein:

[0050] Fig. 1 is a flow chart of a method for identifying and marking a target in

fluoroscopic 3D reconstruction in accordance with the present disclosure;

[0051] Fig. 2 is a schematic diagram of a system configured for use with the

method of Fig. 1;

[0052] Fig. 3A is an exemplary screen shot showing a display of slice images of a

fluoroscopic 3D reconstruction in accordance with the present disclosure;

[0053] Fig. 3B is an exemplary screen shot showing a virtual fluoroscopy image

presented simultaneously with slice images of a fluoroscopic 3D reconstruction in

accordance with the present disclosure;

[0054] Fig. 3C is an exemplary screen shot showing a display of a fluoroscopic 3D

reconstruction in accordance with the present disclosure;

[0055] Fig. 4 is a flow chart of a method for navigating to a target using real-time

two-dimensional fluoroscopic images in accordance with the present disclosure; and

[0056] Fig. 5 is a perspective view of one illustrative embodiment of an exemplary

system for navigating to a soft-tissue target via the airways network in accordance with

the method of Fig. 4.

DETAILED DESCRIPTION

[0057] The term "target", as referred to herein, may relate to any element,

biological or artificial, or to a region of interest in a patient's body, such as a tissue

(including soft tissue and bone tissue), an organ, an implant or a fiducial marker.

[0058] The term "target area", as referred to herein, may relate to the target and

at least a portion of its surrounding area. The term "target area" and the term "body

region" may be used interchangeably when the term "body region" refers to the body

region in which the target is located. Alternatively or in addition, the term "target area"

may also refer to a portion of the body region in which the target is located, all according

to the context.

[0059] The terms "and", "or" and "and/or" may be used interchangeably, while

each term may incorporate the others, all according to the term's context.

[0060] The term "medical device", as referred to herein, may include, without

limitation, optical systems, ultrasound probes, marker placement tools, biopsy tools,

ablation tools (i.e., microwave ablation devices), laser probes, cryogenic probes, sensor

probes, and aspirating needles.

[0061] The terms "fluoroscopic image" and "fluoroscopic images" may refer to

a 2D fluoroscopic image/s and/or to a slice-image of any fluoroscopic 3D reconstructions,

all in accordance with the term's context.

[0062] The terms "virtualfluoroscopic image" or "virtualfluoroscopic images"

may refer to a virtual 2D fluoroscopic image/s and/or to a virtual fluoroscopy slice-image/s

of a virtual fluoroscopic 3D reconstruction or any other 3D reconstruction, all in

accordance with the term's context.

[0063] The present disclosure is directed to systems, methods and computer

program products for facilitating the identification and marking of a target by a user in

real-time fluoroscopic images of a body region of interest generated via a standard

fluoroscope. Such real-time fluoroscopic images may include two-dimensional images

and/or slice-images of a three-dimensional reconstruction. In particular, the identification

and marking of the target in the real-time fluoroscopic data may be facilitated by using

synthetic or virtual fluoroscopic data, which includes a marking or an indication of the

target, as a reference. The virtual fluoroscopic data may be generated from previously

acquired volumetric data and preferably such that it would imitate, as much as possible,

fluoroscopic type of data. Typically, the target is better shown in the imaging modality of

the previously acquired volumetric data than in the real-time fluoroscopic data.

[0064] The present disclosure is further directed to systems and methods for

facilitating the navigation of a medical device to a target and/or its area using real-time

two-dimensional fluoroscopic images of the target area. The navigation is facilitated by

using local three-dimensional volumetric data, in which small soft-tissue objects are

visible, constructed from a sequence of fluoroscopic images captured by a standard

fluoroscopic imaging device available in most procedure rooms. The fluoroscopic-based

constructed local three-dimensional volumetric data may be used to correct a location of a

medical device with respect to a target or may be locally registered with previously

acquired volumetric data. In general, the location of the medical device may be determined

by a tracking system. The tracking system may be registered with the previously acquired

volumetric data. A local registration of the real-time three-dimensional fluoroscopic data

to the previously acquired volumetric data may be then performed via the tracking system.

Such real-time data, may be used, for example, for guidance, navigation planning,

improved navigation accuracy, navigation confirmation, and treatment confirmation.

[0065] Reference is now made to Fig. 1, which is a flow chart of a method for

identifying and marking a target in a 3D fluoroscopic reconstruction in accordance with

the present disclosure. In a step 100, a CT scan and a fluoroscopic 3D reconstruction of a

body region of a patient may be received. The CT scan may include a marking or an

indication of a target located in the patient's body region. Alternatively, a qualified medical

professional may be directed to identify and mark the target in the CT scan. In some

embodiments the target may be a soft-tissue target, such as a lesion. In some embodiments

the imaged body region may include at least a portion of the lungs. In some embodiments,

the 3D reconstructions may be displayed to the user. In some embodiments the 3D

reconstruction may be displayed such that the user may scroll through its different slice

images. Reference is now made to Fig. 3A, which is an exemplary screen shot 300 showing a display of slice images of a fluoroscopic 3D reconstruction in accordance with the present disclosure. Screen shot 300 includes a slice image 310, a scrolling bar 320 and an indicator 330. Scrolling bar 320 allows a user to scroll through the slice images of the fluoroscopic 3D reconstruction. Indicator 330 indicates the relative location of the slice image currently displayed, e.g., slice image 310, within the slice images constituting the fluoroscopic 3D reconstruction.

[0066] In some embodiments, the receiving of the fluoroscopic 3D reconstruction

of the body region may include receiving a sequence of fluoroscopic images of the body

region and generating the fluoroscopic 3D reconstruction of the body region based on at

least a portion of the fluoroscopic images. In some embodiments, the method may further

include directing a user to acquire the sequence of fluoroscopic images by manually

sweeping the fluoroscope. In some embodiments, the method may further include

automatically acquiring the sequence of fluoroscopic images. The fluoroscopic images

may be acquired by a standard fluoroscope, in a continuous manner and about a plurality

of angles relative to the body region. The fluoroscope may be swept manually, i.e., by a

user, or automatically. For example, the fluoroscope may be swept along an angle of 20 to

45 degrees. In some embodiments, the fluoroscope may be swept along an angle of 30±5

degrees.

[0067] In some embodiments, the fluoroscopic 3D reconstruction may be

generated based on tomosynthesis methods, and/or according to the systems and methods

disclosed in US Patent Application No. 2017/035379 and US Patent Application No.

15/892,053, as mentioned above and incorporated herein by reference. The CT scan may

be generated according and via methods and systems as known in the art. The CT scan is

a pre-operative CT scan, i.e., generated previously (i.e., not in real-time) and prior to a

medical procedure for which the identification and marking of the target may be required.

[0068] In a step 110, at least one virtual fluoroscopy image may be generated

based on the CT scan of the patient. The virtual fluoroscopy image can then include the

target and the marking of the target, as indicated in the CT scan. The aim is to generate an

image of the target, which includes a relatively accurate indication of the target, and which

resembles the fluoroscopic type of images. A user may then use the indication of the target

in the synthetic image to identify and mark the target in the real-time fluoroscopic volume

(e.g., by identifying the target in one or more slice images). In some embodiments, the

virtual fluoroscopy image may be of a type of 2D fluoroscopic image, e.g., a virtual 2D

fluoroscopic image. In some embodiments, the virtual fluoroscopy image may be of a type

of fluoroscopic 3D reconstruction slice image, e.g., a virtual slice image.

[0069] In some embodiments, the virtual 2D fluoroscopic image may be generated

based on Digitally Reconstructed Radiograph techniques.

[0070] In some embodiments, the generation of the virtual fluoroscopy slice image

may be generated according to the following steps. In a first step, the received CT volume

is aligned with the fluoroscopic 3D reconstruction. In a second step, an estimation of a

pose of the fluoroscopic device while capturing the set of fluoroscopic images used to

generate the fluoroscopic 3D reconstruction in a selected position, e.g., in AP

(anteroposterior) position, with respect to the target or patient is received or calculated. In

a third step, a slice or slices of the CT scan volume perpendicular to the selected position

and which include the target are generated. In a fourth step, the CT slice or slices are

projected according to the estimated fluoroscope pose to receive a virtual fluoroscopy slice

image.

[0071] In some embodiments, generation of a virtual fluoroscopy slice image of

the target area may include the following steps. In a first step, virtual fluoroscope poses

around the target may be obtained. In some embodiments, the virtual fluoroscope poses may be generated by simulating a fluoroscope trajectory while the fluoroscope scans the target. In some embodiments, the method may further include the generation of the 3D fluoroscopic reconstruction, as described with respect to step 430 of Fig. 4. The estimated poses of the fluoroscopic device while capturing the sequence of fluoroscopic images used to generate the fluoroscopic 3D reconstruction may be then utilized. In a second step, virtual fluoroscopic images may be generated by projecting the CT scan volume according to the virtual fluoroscope poses. In a third step, a virtual fluoroscopic 3D reconstruction may be generated based on the virtual fluoroscopic images. In some embodiments, the virtual fluoroscopic 3D reconstruction may be generated while using the method of reconstruction of the 3D fluoroscopic volume with adaptations. The resulting virtual fluoroscopic volume may then look more like the fluoroscopic volume. For example, the methods of fluoroscopic 3D reconstruction disclosed in US Patent Application No.

2017/035379, US Patent Application No. 2017/035380 and US Patent Application No.

15/892,053, as detailed above and herein incorporated by reference, may be used. In a

fourth step, a slice image which includes the indication of the target may be selected from

the virtual fluoroscopic 3D reconstruction.

[0072] In some embodiments, when marking of the target in a slice image of a

fluoroscopic 3D reconstruction is desired, generating and using a virtual slice image as a

reference may be more advantageous. In some embodiments, when marking of the target

in a fluoroscopic 2D image is desired, generating and using a virtual fluoroscopic 2D

image may be more advantageous.

[0073] In a step 120, the virtual fluoroscopy image and the fluoroscopic 3D

reconstruction may be displayed to a user. The indication of the target in the virtual

fluoroscopy image may be then used as a reference for identifying and marking the target

in slice images of the fluoroscopic 3D reconstruction. Thus, facilitating the identification and marking of the target in the fluoroscopic 3D reconstruction. The identification and marking of the target performed by the user may be then more accurate. A user may use the virtual fluoroscopy as a reference prior to the identification and marking of the target in the real-time fluoroscopic images and/or may use it after such identification and marking.

[0074] Various workflows and displays may be used to identify and mark the target

while using virtual fluoroscopic data as a reference according to the present disclosure.

Such displays are exemplified in Figs. 3B and 3C. Reference is now made to Fig. 3B,

which is an exemplary screen shot 350 showing a virtual fluoroscopy image 360 displayed

simultaneously with fluoroscopic slice images 310a and 310b of a fluoroscopic 3D

reconstruction in accordance with the present disclosure. Screen shot 350 includes a virtual

fluoroscopy image 360, fluoroscopic slice images 310a and 310b, scroll bar 320 and

indicator 330. Virtual fluoroscopy image 360 includes a circular marking 370 of a target.

Fluoroscopic slice images 310a and 310b include circular markings 380a and 380b of the

target correspondingly performed by a user. In some embodiments, the user may visually

align between fluoroscopic slice images 310a and 310b and markings 380a and 380b and

virtual fluoroscopic image 360 and marking 370 to verify markings 380a and 380b. In

some embodiments, the user may use virtual fluoroscopic image 360 and marking 370 to

mark fluoroscopic slice images 310a and 310b. In this specific example, two fluoroscopic

slice images are displayed simultaneously. However, according to other embodiments,

only one fluoroscopic slice image may be displayed or more than two. In this specific

example, the virtual fluoroscopy image is displayed in the center of the screen and the

fluoroscopic slice images are displayed in the bottom sides of the screen. However, any

other display arrangement may be used.

[0075] Reference is now made to Fig. 3C, which is an exemplary screen shot 355

showing a display of at least a portion of a 3D fluoroscopic reconstruction 365. Screen

shot 355 includes the 3D reconstruction image 365, which includes at least a portion (e.g.,

a slice) of the 3D fluoroscopic reconstruction; delimited areas 315a and 315b, scroll bar

325, indicator 335 and button 375. Delimited areas 315a and 315b are specified areas for

presenting slice images of the portion of the 3D reconstruction presented in 3D

reconstruction image 365 selected by the user (e.g., selected by marking the target in these

slice images). Button 374 is captioned "Planned Target". In some embodiments, once the

user press or click button 374, he is presented with at least one virtual fluoroscopic image

showing the target and a marking of it to be used as reference. Once button 374 is pressed,

the display may change. In some embodiments, the display presented once button 374 is

pressed may include virtual fluoroscopy images only. In some embodiments, the display

presented once button 374 is pressed may include additional images, including slice

images of the 3D reconstruction. Scroll bar 325, and indicator 335 may be used by the user

to scroll through slices of at least the portion of the 3D reconstruction presented in 3D

reconstruction image 365.

[0076] In some embodiments, the virtual fluoroscopy image and the fluoroscopic

3D reconstruction (e.g., a selected slice of the fluoroscopic 3D reconstruction) may be

displayed to a user simultaneously. In some embodiments, the virtual fluoroscopy image

and the fluoroscopic 3D reconstruction may be displayed in a non-simultaneous manner.

For example, the virtual fluoroscopy image may be displayed in a separate alternative

screen or in a pop-up window.

[0077] In an optional step 130, the user may be directed to identify and mark the

target in the fluoroscopic 3D reconstruction. In some embodiments, the user may be

specifically directed to use the virtual fluoroscopy image/s as a reference. In some embodiments, the user may be instructed to identify and mark the target in two fluoroscopic slice images of the fluoroscopic 3D reconstruction captured at two different angles. Marking the target in two fluoroscopic slice images may be required when the slice width is relatively thick, and such that additional data would be required to accurately determine the location of the target in the fluoroscopic 3D reconstruction. In some embodiments, the user may need or may be required to only identify the target and may be directed accordingly. In some embodiments, the target may be automatically identified in the fluoroscopic 3D reconstruction by a dedicated algorithm. The user may be then required to confirm and optionally amend the automatic marking using the virtual fluoroscopy image as a reference.

[0078] In some embodiments, the identification and marking of a target may be

performed in one or more two-dimensional fluoroscopic images, i.e., fluoroscopic images

as originally captured. One or more fluoroscopic images may be then received and

displayed to the user instead of the fluoroscopic 3D reconstruction. The identification and

marking of the target by a user may be then performed with respect to the received one or

more fluoroscopic images.

[0079] In some embodiments, the set of two-dimensional fluoroscopic images

(e.g., as originally captured), which was used to construct the fluoroscopic 3D

reconstruction, may be additionally received (e.g., in addition to the 3D fluoroscopic

reconstruction). The fluoroscopic 3D reconstruction, the corresponding set of

two-dimensional fluoroscopic images and the virtual fluoroscopy image may be displayed

to the user. The user may then select if to identify and mark the target in one or more slice

images of the fluoroscopic 3D reconstruction, one or more images of the two-dimensional

fluoroscopic images or in both.

[0080] Reference is now made to Fig. 2, which is a schematic diagram of a system

200 configured for use with the method of Fig. 1. System 200 may include a workstation

80, and optionally a fluoroscopic imaging device or fluoroscope 215. In some

embodiments, workstation 80 may be coupled with fluoroscope 215, directly or indirectly,

e.g., by wireless communication. Workstation 80 may include a memory or storage device

202, a processor 204, a display 206 and an input device 210. Processor or hardware

processor 204 may include one or more hardware processors. Workstation 80 may

optionally include an output module 212 and a network interface 208. Memory 202 may

store an application 81 and image data 214. Application 81 may include instructions

executable by processor 204, inter alia, for executing the method steps of Fig. 1.

Application 81 may further include a user interface 216. Image data 214 may include the

CT scan, the fluoroscopic 3D reconstructions of the target area and /or any other

fluoroscopic image data and/or the generated one or more virtual fluoroscopy images.

Processor 204 may be coupled with memory 202, display 206, input device 210, output

module 212, network interface 208 and fluoroscope 215. Workstation 80 may be a

stationary computing device, such as a personal computer, or a portable computing device

such as a tablet computer. Workstation 80 may embed a plurality of computer devices.

[0081] Memory 202 may include any non-transitory computer-readable storage

media for storing data and/or software including instructions that are executable by

processor 204 and which control the operation of workstation 80 and in some

embodiments, may also control the operation of fluoroscope 215. Fluoroscope 215 may

be used to capture a sequence of fluoroscopic images based on which the fluoroscopic 3D

reconstruction is generated. In an embodiment, memory or storage device 202 may include

one or more storage devices such as solid-state storage devices such as flash memory

chips. Alternatively, or in addition to the one or more solid-state storage devices, memory

202 may include one or more mass storage devices connected to the processor 204 through

a mass storage controller (not shown) and a communications bus (not shown). Although

the description of computer-readable media contained herein refers to a solid-state storage,

it should be appreciated by those skilled in the art that computer-readable storage media

can be any available media that can be accessed by the processor 204. That is, computer

readable storage media may include non-transitory, volatile and non-volatile, removable

and non-removable media implemented in any method or technology for storage of

information such as computer-readable instructions, data structures, program modules or

other data. For example, computer-readable storage media may include RAM, ROM,

EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM,

DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk

storage or other magnetic storage devices, or any other medium which may be used to

store the desired information, and which may be accessed by workstation 80.

[0082] Application 81 may, when executed by processor 204, cause display 206 to

present user interface 216. User interface 216 may be configured to present to the user the

fluoroscopic 3D reconstruction and the generated virtual fluoroscopy image, as shown, for

example, in Figs. 3A and 3B. User interface 216 may be further configured to direct the

user to identify and mark the target in the displayed fluoroscopic 3D reconstruction or any

other fluoroscopic image data in accordance with the present disclosure.

[0083] Network interface 208 may be configured to connect to a network such as

a local area network (LAN) consisting of a wired network and/or a wireless network, a

wide area network (WAN), a wireless mobile network, a Bluetooth network, and/or the

internet. Network interface 208 may be used to connect between workstation 80 and

fluoroscope 215. Network interface 208 may be also used to receive image data 214. Input

device 210 may be any device by means of which a user may interact with workstation 80, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface.

Output module 212 may include any connectivity port or bus, such as, for example, parallel

ports, serial ports, universal serial busses (USB), or any other similar connectivity port

known to those skilled in the art.

[0084] Reference is now made to Fig. 4, which is a flow chart of a method for

navigating to a target using real-time two-dimensional fluoroscopic images in accordance

with the present disclosure. The method facilitates navigating to a target area within a

patient's body during a medical procedure. The method utilizes real-time fluoroscopic

based three-dimensional volumetric data. The fluoroscopic three-dimensional volumetric

data may be generated from two-dimensional fluoroscopic images.

[0085] In a step 400, a pre-operative CT scan of the target area may be received.

The pre-operative CT scan may include a marking or indication of the target. Step 400

may be similar to step 100 of the method of Fig. 1.

[0086] In a step 410, one or more virtual fluoroscopy images may be generated

based on the pre-operative CT scan. The virtual fluoroscopy images may include the target

and the marking or indication of the target. Step 400 may be similar to step 110 of the

method of Fig. 1.

[0087] In a step 420, a sequence of fluoroscopic images of the target area acquired

in real time about a plurality of angles relative to the target area may be received. The

sequence of images may be captured while a medical device is positioned in the target

area. In some embodiments, the method may include further steps for directing a user to

acquire the sequence of fluoroscopic images. In some embodiments, the method may

include one or more further steps for automatically acquiring the sequence of fluoroscopic

images.

[0088] In a step 430, a three-dimensional reconstruction of the target area may be

generated based on the sequence of fluoroscopic images.

[0089] In some embodiments, the method further comprises one or more steps for

estimating the pose of the fluoroscopic imaging device while acquiring each of the

fluoroscopic images, or at least a plurality of them. The three-dimensional reconstruction

of the target area may be then generated based on the pose estimation of the fluoroscopic

imaging device.

[0090] In some embodiments, a structure of markers may be placed with respect

to the patient and the fluoroscopic imaging device, such that each fluoroscopic image

includes a projection of at least a portion of the structure of markers. The estimation of the

pose of the fluoroscopic imaging device while acquiring each image may be then

facilitated by the projections of the structure of markers on the fluoroscopic images. In

some embodiments, the estimation may be based on detection of a possible and most

probable projection of the structure of markers as a whole on each image.

[0091] Exemplary systems and methods for constructing such fluoroscopic-based

three-dimensional volumetric data are disclosed in the above commonly owned U.S.

Patent Publication No. 2017/0035379, US Patent Application No. 15/892,053 and U.S.

Provisional Application Serial No. 62/628,017, which are incorporated by reference.

[0092] In some embodiments, once the pose estimation process is complete, the

projection of the structure of markers on the images may be removed by using well known

methods. One such method is disclosed in commonly-owned U.S. Patent Application No.

62/628,028, entitled: "IMAGE RECONSTRUCTION SYSTEM AND METHOD", filed

on February 8, 2018, to Alexandroni et al., the entire content of which is hereby

incorporated by reference.

[0093] In a step 440, one or more virtual fluoroscopy images and the fluoroscopic

3D reconstruction may be displayed to a user. The display may be according to step 120

of the method of Fig. 1 and as exemplified in Fig. 3B. In some embodiments, one or more

virtual fluoroscopy images and the fluoroscopic 3D reconstruction may be displayed to a

user simultaneously. In some embodiments, the virtual fluoroscopy image and the

fluoroscopic 3D reconstruction may be displayed in a non-simultaneous manner. For

example, the virtual fluoroscopy image may be displayed in a separate screen or may be

displayed, e.g., upon the user's request, instead of the display of the fluoroscopic 3D

reconstruction.

[0094] In a step 450, a selection of the target from the fluoroscopic 3D

reconstruction may be received via the user. In some embodiments, the user may be

directed to identify and mark the target in the fluoroscopic 3D reconstruction while using

the one or more virtual fluoroscopy images as a reference.

[0095] In a step 460, a selection of the medical device from the three-dimensional

reconstruction or the sequence of fluoroscopic images may be received. In some

embodiments, the receipt of the selection may include automatically detecting at least a

portion of the medical device in the sequence of fluoroscopic images or three-dimensional

reconstruction. In some embodiments, a user command either accepting or rejecting the

detection may be also received. In some embodiments the selection may be received via

the user. Exemplary automatic detection of a catheter in fluoroscopic images is disclosed

in commonly-owned US Provisional Application No. 62/627,911 to Weingarten et al.,

entitled "System And Method For Catheter Detection In Fluoroscopic Images And

Updating Displayed Position Of Catheter", the contents of which are incorporated herein

by reference.

[0096] In a step 470, an offset of the medical device with respect to the target may

be determined. The determination of the offset may be based on the received selections of

the target and the medical device.

[0097] In some embodiments, the method may further include a step for

determining the location of the medical device within the patient's body based on data

provided by a tracking system, such as an electromagnetic tracking system. In a further

step, the target area and the location of the medical device with respect to the target may

be displayed to the user on a display. In another step, the display of the location of the

medical device with respect to the target may be corrected based on the determined offset

between the medical device and the target.

[0098] In some embodiments, the method may further include a step for generating

a 3D rendering of the target area based on the pre-operative CT scan. A display of the

target area may then include a display of the 3D rendering. In another step, the tracking

system may be registered with the 3D rendering. A correction of the location of the medical

device with respect to the target based on the determined offset may then include the local

updating of the registration between the tracking system and the 3D rendering in the target

area. In some embodiments, the method may further include a step for registering the

fluoroscopic 3D reconstruction to the tracking system. In another step and based on the

above, a local registration between the fluoroscopic 3D reconstruction and the 3D

rendering may be performed in the target area.

[0099] In some embodiments, the target may be a soft tissue target. In some

embodiments, the target area may include at least a portion of the lungs and the medical

device may be configured to be navigated to the target area through the airways luminal

network.

[00100] In some embodiments, the method may include receiving a selection of the

target from one or more images of the sequence of fluoroscopy images in addition or

alternatively to receiving a selection of the target from the fluoroscopic 3D reconstruction.

The sequence of fluoroscopy images may be then displayed to the user in addition or

instead of the display of the fluoroscopic 3D reconstruction correspondingly. The method

of Fig. 4 should be then adapted accordingly.

[00101] A computer program product for navigating to a target using real-time

two-dimensional fluoroscopic images is herein disclosed. The computer program product

may include a non-transitory computer-readable storage medium having program code

embodied therewith. The program code may be executable by at least one hardware

processor to perform the steps of the method of Fig. 1 and/or Fig. 4.

[00102] Fig. 5 is a perspective view of one illustrative embodiment of an exemplary

system for facilitating navigation to a soft-tissue target via the airways network in

accordance with the method of Fig. 4. System 500 may be further configured to construct

fluoroscopic-based three-dimensional volumetric data of the target area from 2D

fluoroscopic images. System 500 may be further configured to facilitate approach of a

medical device to the target area by using Electromagnetic Navigation Bronchoscopy

(ENB) and for determining the location of a medical device with respect to the target.

[00103] System 500 may be configured for reviewing CT image data to identify one

or more targets, planning a pathway to an identified target (planning phase), navigating an

extended working channel (EWC) 512 of a catheter assembly to a target (navigation phase)

via a user interface, and confirming placement of EWC 512 relative to the target. One

such EMN system is the ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY@

system currently sold by Medtronic PLC. The target may be tissue of interest identified

by review of the CT image data during the planning phase. Following navigation, a medical device, such as a biopsy tool or other tool, may be inserted into EWC 512 to obtain a tissue sample from the tissue located at, or proximate to, the target.

[00104] As shown in Fig. 5, EWC 512 is part of a catheter guide assembly 540. In

practice, EWC 512 is inserted into a bronchoscope 530 for access to a luminal network of

the patient "P." Specifically, EWC 512 of catheter guide assembly 540 may be inserted

into a working channel of bronchoscope 530 for navigation through a patient's luminal

network. A locatable guide (LG) 532, including a sensor 544 is inserted into EWC 512

and locked into position such that sensor 544 extends a desired distance beyond the distal

tip of EWC 512. The position and orientation of sensor 544 relative to the reference

coordinate system, and thus the distal portion of EWC 512, within an electromagnetic field

can be derived. Catheter guide assemblies 540 are currently marketed and sold by

Medtronic PLC under the brand names SUPERDIMENSION@ Procedure Kits, or

EDGETM Procedure Kits, and are contemplated as useable with the present disclosure. For

a more detailed description of catheter guide assemblies 540, reference is made to

commonly-owned U.S. Patent Publication No. 2014/0046315, filed on March 15, 2013,

by Ladtkow et al, U.S. Patent No. 7,233,820, and U.S. Patent No. 9,044,254, the entire

contents of each of which are hereby incorporated by reference.

[00105] System 500 generally includes an operating table 520 configured to support

a patient "P," a bronchoscope 530 configured for insertion through the patient's "P's"

mouth into the patient's "P's" airways; monitoring equipment 535 coupled to

bronchoscope 530 (e.g., a video display, for displaying the video images received from the

video imaging system of bronchoscope 530); a locating or tracking system 550 including

a locating module 552, a plurality of reference sensors 554 and a transmitter mat coupled

to a structure of markers 556; and a computing device 525 including software and/or

hardware used to facilitate identification of a target, pathway planning to the target, navigation of a medical device to the target, and/or confirmation and/or determination of placement of EWC 512, or a suitable device therethrough, relative to the target.

Computing device 525 may be similar to workstation 80 of Fig. 2 and may be configured,

inter alia, to execute the methods of Fig. 1 and Fig. 4.

[00106] A fluoroscopic imaging device 510 capable of acquiring fluoroscopic or x

ray images or video of the patient "P" is also included in this particular aspect of system

500. The images, sequence of images, or video captured by fluoroscopic imaging device

510 may be stored within fluoroscopic imaging device 510 or transmitted to computing

device 525 for storage, processing, and display, e.g., as described with respect to Fig. 2.

Additionally, fluoroscopic imaging device 510 may move relative to the patient "P" so

that images may be acquired from different angles or perspectives relative to patient "P"

to create a sequence of fluoroscopic images, such as a fluoroscopic video. The pose of

fluoroscopic imaging device 510 relative to patient "P" and while capturing the images

may be estimated via structure of markers 556 and according to the method of Fig. 4. The

structure of markers is positioned under patient "P", between patient "P" and operating

table 520 and may be positioned between patient "P" and a radiation source or a sensing

unit of fluoroscopic imaging device 510. The structure of markers is coupled to the

transmitter mat (both indicated 556) and positioned under patient "P" on operating table

520. Structure of markers and transmitter map 556 are positioned under the target area

within the patient in a stationary manner. Structure of markers and transmitter map 556

may be two separate elements which may be coupled in a fixed manner or alternatively

may be manufactured as a single unit. Fluoroscopic imaging device 510 may include a

single imaging device or more than one imaging device. In embodiments including

multiple imaging devices, each imaging device may be a different type of imaging device or the same type. Further details regarding the imaging device 510 are described in U.S.

Patent No. 8,565,858, which is incorporated by reference in its entirety herein.

[00107] Computing device 525 may be any suitable computing device including a

processor and storage medium, wherein the processor is capable of executing instructions

stored on the storage medium. Computing device 525 may further include a database

configured to store patient data, CT data sets including CT images, fluoroscopic data sets

including fluoroscopic images and video, fluoroscopic 3D reconstruction, navigation

plans, and any other such data. Although not explicitly illustrated, computing device 525

may include inputs, or may otherwise be configured to receive, CT data sets, fluoroscopic

images/video and other data described herein. Additionally, computing device 525

includes a display configured to display graphical user interfaces. Computing device 525

may be connected to one or more networks through which one or more databases may be

accessed.

[00108] With respect to the planning phase, computing device 525 utilizes

previously acquired CT image data for generating and viewing a three-dimensional model

or rendering of the patient's "P's" airways, enables the identification of a target on the

three-dimensional model (automatically, semi-automatically, or manually), and allows for

determining a pathway through the patient's "P's" airways to tissue located at and around

the target. More specifically, CT images acquired from previous CT scans are processed

and assembled into a three-dimensional CT volume, which is then utilized to generate a

three-dimensional model of the patient's "P's" airways. The three-dimensional model may

be displayed on a display associated with computing device 525, or in any other suitable

fashion. Using computing device 525, various views of the three-dimensional model or

enhanced two-dimensional images generated from the three-dimensional model are

presented. The enhanced two-dimensional images may possess some three-dimensional capabilities because they are generated from three-dimensional data. The three-dimensional model may be manipulated to facilitate identification of target on the three-dimensional model or two-dimensional images, and selection of a suitable pathway through the patient's "P's" airways to access tissue located at the target can be made. Once selected, the pathway plan, three-dimensional model, and images derived therefrom, can be saved and exported to a navigation system for use during the navigation phase(s). One such planning software is the ILOGIC@ planning suite currently sold by Medtronic PLC.

[00109] With respect to the navigation phase, a six degrees-of-freedom

electromagnetic locating or tracking system 550, e.g., similar to those disclosed in U.S.

Patent Nos. 8,467,589, 6,188,355, and published PCT Application Nos. WO 00/10456 and

WO 01/67035, the entire contents of each of which are incorporated herein by reference,

or other suitable system for determining location, is utilized for performing registration of

the images and the pathway for navigation, although other configurations are also

contemplated. Tracking system 550 includes a locating or tracking module 552, a plurality

of reference sensors 554, and a transmitter mat 556 (coupled with the structure of markers).

Tracking system 550 is configured for use with a locatable guide 532 and particularly

sensor 544. As described above, locatable guide 532 and sensor 544 are configured for

insertion through EWC 512 into a patient's "P's" airways (either with or without

bronchoscope 530) and are selectively lockable relative to one another via a locking

mechanism.

[00110] Transmitter mat 556 is positioned beneath patient "P." Transmitter mat

556 generates an electromagnetic field around at least a portion of the patient "P" within

which the position of a plurality of reference sensors 554 and the sensor element 544 can

be determined with use of a tracking module 552. One or more of reference sensors 554

are attached to the chest of the patient "P." The six degrees of freedom coordinates of reference sensors 554 are sent to computing device 525 (which includes the appropriate software) where they are used to calculate a patient coordinate frame of reference.

Registration is generally performed to coordinate locations of the three-dimensional model

and two-dimensional images from the planning phase, with the patient's "P's" airways as

observed through the bronchoscope 530, and allow for the navigation phase to be

undertaken with precise knowledge of the location of the sensor 544, even in portions of

the airway where the bronchoscope 530 cannot reach. Further details of such a registration

technique and their implementation in luminal navigation can be found in U.S. Patent

Application Pub. No. 2011/0085720, the entire content of which is incorporated herein by

reference, although other suitable techniques are also contemplated.

[00111] Registration of the patient's "P's" location on the transmitter mat 556 is

performed by moving LG 532 through the airways of the patient's "P." More specifically,

data pertaining to locations of sensor 544, while locatable guide 532 is moving through

the airways, is recorded using transmitter mat 556, reference sensors 554, and tracking

module 552. A shape resulting from this location data is compared to an interior geometry

of passages of the three-dimensional model generated in the planning phase, and a location

correlation between the shape and the three-dimensional model based on the comparison

is determined, e.g., utilizing the software on computing device 525. In addition, the

software identifies non-tissue space (e.g., air filled cavities) in the three-dimensional

model. The software aligns, or registers, an image representing a location of sensor 544

with the three-dimensional model and/or two-dimensional images generated from the

three-dimension model, which are based on the recorded location data and an assumption

that locatable guide 532 remains located in non-tissue space in the patient's "P's" airways.

Alternatively, a manual registration technique may be employed by navigating the

bronchoscope 530 with the sensor 544 to pre-specified locations in the lungs of the patient

"P", and manually correlating the images from the bronchoscope to the model data of the

three-dimensional model.

[00112] Following registration of the patient "P" to the image data and pathway

plan, a user interface is displayed in the navigation software which sets for the pathway

that the clinician is to follow to reach the target. One such navigation software is the

ILOGIC@ navigation suite currently sold by Medtronic PLC.

[00113] Once EWC 512 has been successfully navigated proximate the target as

depicted on the user interface, the locatable guide 532 may be unlocked from EWC 512

and removed, leaving EWC 512 in place as a guide channel for guiding medical devices

including without limitation, optical systems, ultrasound probes, marker placement tools,

biopsy tools, ablation tools (i.e., microwave ablation devices), laser probes, cryogenic

probes, sensor probes, and aspirating needles to the target.

[00114] A medical device may be then inserted through EWC 512 and navigated to

the target or to a specific area adjacent to the target. A sequence of fluoroscopic images

may be then acquired via fluoroscopic imaging device 510, optionally by a user and

according to directions displayed via computing device 525. A fluoroscopic 3D

reconstruction may be then generated via computing device 525. The generation of the

fluoroscopic 3D reconstruction is based on the sequence of fluoroscopic images and the

projections of structure of markers 556 on the sequence of images. One or more virtual

fluoroscopic images may be then generated based on the pre-operative CT scan and via

computing device 525. The one or more virtual fluoroscopic images and the fluoroscopic

3D reconstruction may be then displayed to the user on a display via computing device

525, optionally simultaneously. The user may be then directed to identify and mark the

target while using the virtual fluoroscopic image as a reference. The user may be also

directed to identify and mark the medical device in the sequence of fluoroscopic

2D-dimensional images. An offset between the location of the target and the medical

device may be then determined or calculated via computer device 525. The offset may be

then utilized, via computing device 525, to correct the location of the medical device on

the display with respect to the target and/or correct the registration between the

three-dimensional model and tracking system 550 in the area of the target and/or generate

a local registration between the three-dimensional model and the fluoroscopic 3D

reconstruction in the target area.

[00115] System 500 or a similar version of it in conjunction with the method of Fig.

4 may be used in various procedures, other than ENB procedures with the required obvious

modifications, and such as laparoscopy or robotic assisted surgery.

[00116] The terms "tracking" or "localization", as referred to herein, may be used

interchangeably. Although the present disclosure specifically describes the use of an EM

tracking system to navigate or determine the location of a medical device, various tracking

systems or localization systems may be used or applied with respect to the methods and

systems disclosed herein. Such tracking, localization or navigation systems may use

various methodologies including electromagnetic, Infra-Red, echolocation, optical or

imaging-based methodologies. Such systems may be based on pre-operative imaging

and/or real-time imaging.

[00117] In some embodiments, the standard fluoroscope may be employed to

facilitate navigation and tracking of the medical device, as disclosed, for example, in US

Patent No. 9,743,896 to Averbuch. For example, such fluoroscopy-based localization or

navigation methodology may be applied in addition to or instead of the above-mentioned

EM tracking methodology, e.g., as described with respect to Fig. 5, to facilitate or enhance

navigation of the medical device.

[00118] From the foregoing and with reference to the various figure drawings, those

skilled in the art will appreciate that certain modifications can also be made to the present

disclosure without departing from the scope of the same.

[00119] Detailed embodiments of the present disclosure are disclosed herein.

However, the disclosed embodiments are merely examples of the disclosure, which may

be embodied in various forms and aspects. Therefore, specific structural and functional

details disclosed herein are not to be interpreted as limiting, but merely as a basis for the

claims and as a representative basis for teaching one skilled in the art to variously employ

the present disclosure in virtually any appropriately detailed structure.

[00120] While several embodiments of the disclosure have been shown in the

drawings, it is not intended that the disclosure be limited thereto, as it is intended that the

disclosure be as broad in scope as the art will allow and that the specification be read

likewise. Therefore, the above description should not be construed as limiting, but merely

as exemplifications of embodiments. Those skilled in the art will envision other

modifications within the scope and spirit of the claims appended hereto.

Claims

CLAIMS:

1. A system for facilitating identification and marking of a target in a target area in a

fluoroscopic image of a body region of a patient, the system comprising:

(i) one or more storage devices having stored thereon instructions for:

receiving a CT scan of the body region of the patient, wherein the CT scan includes a

marking of the target;

receiving a sequence of fluoroscopic images including the target area acquired in real

time about a plurality of angles relative to the target, while a medical device is positioned in

proximity to the target; and

generating a fluoroscopic 3D reconstruction based on at least a portion of the sequence

of fluoroscopic images;

generating at least one virtual fluoroscopic image based on the CT scan of the patient,

wherein the virtual fluoroscopic image includes the target and the marking of the target,

receiving a selection of the target in the fluoroscopic 3D reconstruction via a user

input;

receiving a selection of the medical device in the 3D reconstruction or the sequence

of fluoroscopic images;

determining an offset of the medical device with respect to the target based on the

selections of the target and the medical device;

determining a location of the medical device within the patient based on data provided

by a tracking system;

displaying the target area and the location of the medical device with respect to the

target on a display; and

correcting the display of the location of the medical device with respect to the target

based on the offset between the medical device and the target; and

(ii) at least one hardware processor configured to execute said instructions.

2. The system of claim 1, wherein the one or more storage devices have stored thereon

further instructions for directing the user to identify and mark the target in the fluoroscopic

3D reconstruction while using the virtual fluoroscopic image as a reference.

3. The system of claim 2, wherein the user is directed to identify and mark the target in

two fluoroscopic slice images of the fluoroscopic 3D reconstruction.

4. The system of any one of the preceding claims, wherein the generating of the at least

one virtual fluoroscopic image comprises:

generating virtual fluoroscope poses around the target by simulating a fluoroscope

trajectory while scanning the target;

generating virtual fluoroscopic images by projecting the CT scan according to the

virtual fluoroscope poses;

generating virtual fluoroscopic 3D reconstruction based on the virtual fluoroscopic

images; and

selecting a slice image from the virtual fluoroscopic 3D reconstruction which

comprises the marking of the target.

5. The system of any one of the preceding claims, wherein the target is a soft-tissue

target.

Covidien LP Patent Attorneys for the Applicant/Nominated Person SPRUSON&FERGUSON